Intrauterine treatment device with articulating array

ABSTRACT

An intrauterine device includes an articulating array. The intrauterine device can be operated by articulating the articulating array into an installed position or geometry within the uterus of a patient. Further, the articulating array can be constructed to include an insertion geometry have a smaller cross section than an installation geometry. The articulating array can also be constructed to be housed within a sheath in the intrauterine device. Once the sheath has been inserted into a patient, for example through the patient&#39;s cervix, the articulating array can be deployed in its insertion geometry and then articulated into an installed position. The articulating array can include a plurality of expansion chambers. The expansion chambers can be constructed and arranged to take on the installed geometry when expanded. In one embodiment, the purpose of the articulating array is to position a conductive array within the patient&#39;s uterus enabling ablation of the uterine lining.

RELATED APPLICATION DATA

The present application is a continuation of U.S. patent applicationSer. No. 13/800,352, filed Mar. 13, 2013, now issued as U.S. Pat. No.9,895,192, the priority of which is claimed under 35 U.S.C. § 120, andthe contents of which is incorporated herein by reference in itsentirety, as though set forth in full.

BACKGROUND

Intrauterine medical devices are often inserted through a patient'scervix and then expanded inside the patient's uterus. For example, auterine ablation procedure may be performed by inserting a medicaldevice having a sheath through the cervix and then extending an ablationdevice through the distal end of the sheath and expanding the ablationdevice in the uterus. The ablation device can be expanded inside thepatient, out of view of the person performing the procedure. Deploymentof such medical devices and/or ablation devices and their subsequentrobustness can be important to avoid complications and potential injuryto the patient during a procedure.

SUMMARY

Conventional intrauterine medical devices employed, for example, foruterine ablation oftentimes rely on expanding a rigid structure inside apatient into a fixed geometry. It is realized that the ability toposition such conventional devices can be limited by the structure ofthe device itself, and additionally the ability to conform to theintended area inside the patient can likewise be limited. Further, rigidportions of such conventional devices present perforation risk to thepatient undergoing the procedure, where the structures of the treatmentdevice cause internal wounds or perforations during the procedure.

Accordingly, provided are flexible intrauterine medical devices havingsoft articulating arrays. The articulating arrays can include aplurality of chambers that when expanded cause the articulating array totransition into an installed position, for example, within the uterus ofthe patient. In some embodiments, the plurality of chambers can beconfigured to transition between an insertion geometry and an installedgeometry, where the insertion geometry is configured to have a smallcross section relative to the installed geometry. The soft articulatingarrays can be advantageous because the soft articulating array has norigid structures to increase perforation risk. Furthermore the smallerinsertion geometry can permit intrauterine devices having smaller crosssections, which can reduce difficulty in insertion and reduce patientdiscomfort during such procedures. The soft articulating arrays can bearticulated from an insertion geometry into an installed position by,for example, inflating a plurality of chambers within the articulatingarray. Selective and/or controlled inflation of the plurality ofchambers can cause the articulating array to take on a variety ofgeometries for the installed positions. In some embodiments, thearticulating array can reach a roughly triangular geometry once in aninstalled position/geometry.

In some embodiments, the articulation of the articulating array into theinstalled position can enable greater intimate contact over a largersurface area within the patient over some conventional devices. Thegreater contacting surface area can improve robustness of thepositioning of the device during any procedure. Further aspects andembodiment are directed to reducing the diameter of the sheath used inconjunction with the articulating array of an intrauterine device whilemaintaining the strength and robustness of the device. Reducing thediameter of the sheath of an intrauterine device improves its ease ofinsertion and decreases patient discomfort.

According to one aspect, an intrauterine device is provided. Theintrauterine device comprises a sheath, an articulating array disposedwithin the sheath during insertion of the intrauterine device, whereinthe articulating array includes a plurality of expansion chambers, aninsertion geometry maintained when the plurality of expansion chambersare in a non-expanded position, and an installed geometry maintainedwhen the plurality of expansion chambers are in an expanded position,and a conductive array on a surface of the articulating array, whereinthe conductive array is configured to ablate a uterine surface uponreceiving input power.

According to some embodiments, the intrauterine device further comprisesan RF generator configured to supply power to the conductive array. Inanother embodiment, the conductive array is disposed on an exteriorsurface of the articulating array. In another embodiment, the conductivearray is constructed and arranged to ablate the uterine surface when thearticulating array is configured in the installed geometry.

In another embodiment, the articulating array further comprises aplurality of channels connected to the plurality of expansion chambersfor controlling pressure within the plurality of expansion chambers. Inanother embodiment, the intrauterine device further comprises a pressurecontroller configured to increase or decrease pressure in the pluralityof expansion chambers. In another embodiment, the articulating arraytransitions between the insertion geometry and the installed geometryresponsive to increased pressure delivered by the pressure controller.In another embodiment, the articulating array transitions between theinstallation geometry and the insertion geometry responsive to decreasedpressure in the plurality of expansion chambers. In another embodiment,the pressure controller is configured to alter pressure in the pluralityof expansion chambers in response to physical manipulation. In anotherembodiment, the pressure controller is configured to operate a pump toincrease pressure in the plurality of expansion chambers. In anotherembodiment, the plurality of expansion chambers are constructed andarranged of high elongation silicone. In another embodiment, thearticulating array is constructed and arranged of a flexible materialhaving a plurality of elasticities.

In another embodiment, the articulating array further comprises the atleast one sensor for establishing position of the articulating array. Inanother embodiment, the at least one sensor includes a contact sensor onan exterior portion of the articulating application while thearticulating array is in the installed geometry. In another embodiment,the at least one sensor includes a strain gauge.

According to one aspect, an intrauterine device is provided. Theintrauterine device comprises an articulating array, wherein thearticulating array includes a plurality of expansion chambers, aninsertion geometry maintained when the plurality of expansion chambersare in a non-expanded position, and an installed geometry maintainedwhen the plurality of expansion chambers are in an expanded position,and a conductive array on a surface of the articulating array,configured to ablate a uterine surface upon receiving input power.

In one embodiment, the intrauterine device further comprises a sheathconfigured to enclose the articulating array. In another embodiment, theintrauterine device further comprises a controller configured totransition the articulating array between the installed geometry and theinsertion geometry. In another embodiment, the intrauterine devicefurther comprises wherein a cross section of the installed geometrydefines a substantially triangular shape. In another embodiment, theconductive array is constructed and arranged of at least one electrodearray on the surface of the articulating array.

According to one aspect, an intrauterine ablation device is provided.The intrauterine device comprises an articulating array including aplurality of expansion chambers that provides an insertion geometry ofthe articulating array when the plurality of expansion chambers are in anon-expanded position, and that provides an installed geometry of thearticulating array when the plurality of expansion chambers are in anexpanded position, and a conductive array disposed on a surface of thearticulating array that is configured, in response to receiving an inputpower, to provide a signal to ablate a uterine surface when thearticulating array is in the installed geometry.

In one embodiment, the intrauterine device further comprises an RFgenerator configured to supply the input power to the conductive array.In another embodiment, the conductive array is disposed on an exteriorsurface of the articulating array. In another embodiment, the conductivearray comprises a plurality of electrodes arranged on the surface of thearticulating array. In another embodiment, the conductive array is aconductive array supported by the articulating array. In anotherembodiment, the articulating array further comprises a plurality ofchannels coupled to the plurality of expansion chambers for controllingpressure within the plurality of expansion chambers.

In another embodiment, the intrauterine device further comprises apressure controller coupled to the plurality of channels and configuredto increase or decrease pressure in the plurality of expansion chambers.In another embodiment, the articulating array is configured totransition between the insertion geometry and the installed geometryresponsive to increased pressure provided to the plurality of expansionchambers. In another embodiment, the articulating array is configured totransition between the installation geometry and the insertion geometryresponsive to decreased pressure provided to the plurality of expansionchambers. In another embodiment, the pressure controller comprises apump to increase pressure in the plurality of expansion chambers.

In another embodiment, the plurality of expansion chambers areconstructed and arranged of high elongation silicone. In anotherembodiment, the articulating array is constructed and arranged of aflexible material having a plurality of elasticities. In anotherembodiment, the articulating array further comprises at least one sensorfor sensing a position of the articulating array. In another embodiment,the at least one sensor includes a contact sensor on an exterior portionof the articulating array that senses a position of the articulatingarray while the articulating array in the installed geometry. In anotherembodiment, the at least one sensor includes a strain gauge. In anotherembodiment, the intrauterine device further comprises a sheathconfigured to enclose the articulating array and the conductive array.

In another embodiment, the intrauterine device further comprises acontroller configured to control the pressure within the plurality ofexpansion chambers so as to transition the articulating array betweenthe installed geometry and the insertion geometry. In anotherembodiment, a cross section of the installed geometry defines asubstantially triangular shape.

According to another aspect, a method for facilitating ablation of auterine tissue is provided. The method comprises providing anarticulating array and a conductive array on a surface of thearticulating array, advancing the articulating array and conductivearray in an insertion geometry through a cervix canal and into a uterusof a patient, and transitioning the articulating array and theconductive array between the insertion geometry and an installedgeometry, providing an input power to the conductive array so as toprovide a signal to ablate a uterine surface with the articulating arrayin the installed geometry.

In one embodiment, the act of transitioning the articulating array andthe conductive array includes an act of providing increased pressure tothe plurality of expansion chambers. In one embodiment, the act oftransitioning the articulating array and the conductive array includesan act of providing decreased pressure to the plurality of expansionchambers. In one embodiment, the articulating array and the conductivearray are housed within a sheath, and the act of advancing thearticulating array and the conductive array occurs while housed withinthe sheath. In one embodiment, the method further comprises an act ofextending the articulating array and the conductive array from thesheath into the uterus of the patient.

In one embodiment, the method further comprises an act of generating theinput power with an RF generator coupled to the conductive array. In oneembodiment, the method further comprises an act of controlling pressureprovided to the plurality of expansion chambers through a plurality ofchannels coupled to the plurality of expansion chambers. In oneembodiment, the method further comprises an act of receiving sensor datafrom at least one sensor for sensing a position of the articulatingarray. In one embodiment, the method further comprises an act ofaltering pressure delivered to at least one of the plurality ofexpansion chambers responsive to the act of receiving sensor data fromthe at least one sensor.

According to one aspect an intrauterine ablation device is provided. Thedevice comprises a sheath, an articulating array disposed within thesheath and including a plurality of expansion chambers to provide aninsertion geometry of the articulating array when the plurality ofexpansion chambers are in a non-expanded position, and to provide aninstalled geometry of the articulating array when the plurality ofexpansion chambers are in an expanded position, a conductive arraydisposed on a surface of the articulating array and configured toreceive an input signal, wherein the articulating array is configured toextend from the sheath and to retain the insertion geometry with theplurality of expansion chambers in the non-expanded position; andwherein the plurality of expansion chambers are configured to expand totransition to the installed geometry and the conductive array isconfigured, in response to receiving an input signal, to provide asignal to ablate a uterine surface with the articulating array in theinstalled geometry.

According to one embodiment, the plurality of expansion chambers arearranged in a linear arrangement configured to provide the insertiongeometry. According to one embodiment, the conductive array is aconductive array supported by the articulating array. According to oneembodiment, the articulating array further comprises a plurality ofchannels coupled to the plurality of expansion chambers for controllingpressure within the plurality of expansion chambers. According to oneembodiment, the device further comprises a pressure controller coupledto the plurality of channels and configured to increase or decreasepressure in the plurality of expansion chambers.

According to one embodiment, the articulating array is responsive tochanges in pressure within the plurality of expansion chambers such thatthe plurality of expansion chambers transition between the insertiongeometry and the installed geometry. According to one embodiment, thearticulating array further comprises at least one sensor for sensing aposition of the articulating array. According to one embodiment, the atleast one sensor includes a contact sensor on an exterior portion of thearticulating array that is configured to sense a position of thearticulating array while the articulating array is in the installedgeometry.

According to one embodiment, the at least one sensor includes a straingauge. According to one embodiment, the articulating array furthercomprising a controller configured to control the pressure within theplurality of expansion chambers so as to transition the articulatingarray between the installed geometry and the insertion geometry.

According to one aspect an intrauterine ablation device is provided. Thedevice comprises a sheath, an articulating array disposed within thesheath and including a plurality of expansion chambers to provide aninsertion geometry of the articulating array when the plurality ofexpansion chambers are in a non-expanded position, and to provide aninstalled geometry of the articulating array when the plurality ofexpansion chambers are in an expanded position, wherein the articulatingarray is configured to extend from the sheath and to retain theinsertion geometry with the plurality of expansion chambers in thenon-expanded position, and wherein the plurality of expansion chambersare configured to expand to transition to the installed geometry placingan outer surface of the articulating array proximate to a uterine liningof a patient.

According to one embodiment, the articulating array includes a deliverycomponent for passing fluid proximate to the uterine lining to ablatethe uterine lining. According to one embodiment, the device furthercomprises a controller configured to control the pressure within theplurality of expansion chambers so as to transition the articulatingarray between the installed geometry and the insertion geometry.

According to one aspect a method for facilitating ablation of a uterinetissue is provided. The method comprises providing an articulating arraydisposed within a sheath having a plurality of adjacent expansionchambers arranged in a linear arrangement, the articulating array havingan insertion geometry with the plurality of expansion chambers in anon-expanded position and having an installed geometry with theplurality of expansion chambers in an expanded position, advancing thesheath and articulating array in the insertion geometry through acervical canal and into a uterus of a patient, extending thearticulating array from the sheath while maintaining the plurality ofexpansion chambers in the insertion geometry, expanding the plurality ofexpansion chambers to an expanded position so as to transition thearticulating array and the conductive array between the insertiongeometry and the installed geometry, and executing an ablation operationso as to ablate a uterine surface of the patient with the articulatingarray in the installed geometry.

According to one embodiment, the articulating array includes aconductive array disposed on a surface of the articulating array, andexecuting an ablation operation includes providing an input signal tothe conductive array so as to ablate a uterine surface of the patientwith the articulating array in the installed geometry. According to oneembodiment, maintaining the plurality of expansion chambers in theinsertion geometry includes selectively controlling pressure in theplurality of adjacent expansion chambers. According to one embodiment,expanding the plurality of adjacent expansion chambers includesexpanding a first one of the plurality of expansion chambers such that apositioning of subsequent ones of the plurality of adjacent expansionchambers is modified.

According to one embodiment, the method further comprises an act ofcontrolling pressure provided to the plurality of expansion chambersthrough a plurality of channels coupled to the plurality of expansionchambers. According to one embodiment, the method further comprises anact of receiving sensor data from at least one sensor for sensing aposition of the articulating array. According to one embodiment, themethod further comprises an act of altering pressure delivered to atleast one of the plurality of expansion chambers responsive to the actof receiving sensor data from the at least one sensor.

Still other aspects, embodiments, and advantages of these exemplaryaspects and embodiments, are discussed in detail below. Embodimentsdisclosed herein may be combined with other embodiments in any mannerconsistent with at least one of the principles disclosed herein, andreferences to “an embodiment,” “some embodiments,” “an alternateembodiment,” “various embodiments,” “one embodiment” or the like are notnecessarily mutually exclusive and are intended to indicate that aparticular feature, structure, or characteristic described may beincluded in at least one embodiment. The appearances of such termsherein are not necessarily all referring to the same embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of at least one embodiment are discussed below withreference to the accompanying figures, which are not intended to bedrawn to scale. The figures are included to provide illustration and afurther understanding of the various aspects and embodiments, and areincorporated in and constitute a part of this specification, but are notintended as a definition of the limits of the invention. In the figures,each identical or nearly identical component that is illustrated invarious figures is represented by a like numeral. For purposes ofclarity, not every component may be labeled in every figure. In thefigures:

FIG. 1 is a side elevation view of an intrauterine therapy applicationdevice with an articulating array according to aspects of thedisclosure;

FIG. 2 is a side elevation view of the intrauterine therapy applicationdevice of FIG. 1, showing the articulating array according to aspects ofthe disclosure;

FIG. 3A is a perspective view of an embodiment of an intrauterinetherapy application device with an articulating array in a deployedposition, according to aspects of the disclosure;

FIG. 3B is an elevation view of an embodiment of an intrauterine therapyapplication device with an articulating array in a deployed position,according to aspects of the disclosure;

FIG. 3C is a perspective view of an embodiment of a portion of anintrauterine therapy application device with an articulating arrayshowing a conductive array according to aspects of the disclosure;

FIG. 3D is a perspective view of an embodiment of a portion of anintrauterine therapy application device with an articulating arrayshowing a conductive array according to aspects of the disclosure;

FIGS. 4A-C illustrate installed geometries of embodiments of anarticulating array according to aspects of the disclosure;

FIG. 5 illustrates examples of expansion chambers included in anarticulating array according to aspects of the disclosure;

FIG. 6 illustrates a process for positioning an intrauterine device foran ablation procedure according to aspects of the disclosure; and

FIG. 7 is a block diagram of controller according to aspects of thedisclosure.

DETAILED DESCRIPTION

Various aspects of at least one embodiment are discussed below withreference to the accompanying figures, which are not intended to bedrawn to scale. The figures are included to provide illustration and afurther understanding of the various aspects and embodiments, and areincorporated in and constitute a part of this specification, but are notintended as a definition of the limits of the invention. In the figures,each identical or nearly identical component that is illustrated invarious figures is represented by a like numeral. For purposes ofclarity, not every component may be labeled in every figure.

According to aspects of this disclosure, various structures and methodsare provided herein for decreasing a size or diameter of an intrauterinetherapy application device in an insertion and/or retracted position,while maintaining its strength and robustness in expanded and/ordeployed positions. Further, according to some aspects of the disclosurethe structures and methods provide for more intimate contact between thedevice in an installed geometry and a patient's target cavity reducing,for example, risk of internal perforation during a medical procedure,including, for example, uterine ablation. In at least one embodiment,various structures and methods are provided for maintaining therobustness of a deployment mechanism of an intrauterine therapyapplication device by employing an articulating soft array.

Articulating arrays as discussed herein include a plurality of expansionchambers that can be inflated or deflated to provide one or morepositions of the articulating array. In some embodiments, thearticulating array is constructed of a soft extensible material having aplurality of expansion chambers. During insertion the articulating arraymaintains a small area, cross section, and/or diameter. Once insertedthe articulating array can transition from an insertion geometry into aninstalled position that provides for intimate contact over the surfaceof the area within the patient being operated on by expanding theexpansion chambers.

According to aspects of this disclosure, structures and methods areprovided to decrease the stiffness of the installed device and providefor improved contact between, for example, the uterine lining and theinstalled geometry formed by the articulating array included in anintrauterine therapy application device. Among others, one advantage ofemploying an articulating array is the resulting decrease in the crosssection of the intrauterine device, reducing patient discomfort and/orimproving ease of insertion into an installed position within a patient.Accordingly, intrauterine devices are provided having a reduced size ordiameter in collapsed or retracted position which enable asmaller-diameter sheath while still maintaining the deploymentmechanism's robustness in both collapsed and deployed positions. Anotheradvantage in a smaller outer diameter sheath includes reducing patientdiscomfort and decreasing the potential for cervical injury duringinsertion into the uterus. Further advantages can include the use ofsoft materials including, for example, silicone to fabricate thearticulating arrays of the intrauterine therapy application device.Employing soft and/or flexible materials to construct the articulatingarrays can reduce perforation risk in patients undergoing treatment.

In some embodiments, the articulating array can be housed within asheath that is inserted into a patient. The articulating array or arraycomponent can be extended from the sheath in an insertion geometry. Theinsertion geometry can be configured to minimize the area, crosssection, and/or diameter or the articulating array (and thecorresponding sheath) to provide, for example, for patient comfort. Thearticulating array can then be transitioned from the insertion geometryinto an installed geometry. The installed geometry is configured to haveas much intimate contact with the patient's internals as is possible.The articulating array can be constructed with a conductive arrayconfigured to ablate, for example, the patient's uterine lining duringan ablation procedure once the articulating array is in an installedposition. Reference to a conductive array herein is intended to includean array of conductors disposed on the surface of an articulating, anarray of conductors in the form of a mesh structure that can also bedisposed on the surface of or within an articulating array.Additionally, reference to a conductive array is intended to include theexamples of mesh arrays described in U.S. Pat. No. 6,813,520 to Truckaiet al., which is hereby incorporated by reference herein in itsentirety. In some embodiments, the articulating array can position aconductive array disposed on its surface, and in others be configured todeploy conductive array including a mesh structure of conductors into aposition for ablation.

By way of introduction and referring to the Figures, illustrated in FIG.1 is an intrauterine therapy application device including anarticulating array 102, a sheath 104, and an RF generator 110. Accordingto one embodiment, the sheath of the device is inserted through thepatient's cervix. The articulating array may be retracted in a collapsedor retracted position within the sheath for insertion into the patient'scervix. The sheath may be inserted through the patient's cervix, andwhen the distal end 104A of the sheath is inside the uterus, thearticulating array may be extended into the uterus in an insertiongeometry and articulated into a deployed state or installed geometry inthe uterus. FIG. 3B illustrates an intrauterine therapy applicationdevice array 102 in a deployed or installed position. Decreasing thesize, such as the cross section of an insertion geometry of thearticulating array, allows for use of a smaller-diameter sheath 104. Asheath having a smaller outer diameter may reduce patient discomfort,and also decrease the potential for cervical injury during insertionthrough the cervix and into the uterus.

In some embodiments, the device array 102 includes an articulatingarray, having a plurality of chambers (see e.g., 150 of FIG. 3A). In aninsertion geometry or collapsed position, device array 102 isconstructed and arranged to have a cylindrical structure shown, forexample, in FIG. 3A. The plurality of chambers at 150 can be, forexample, air chambers constructed and arranged to configure array 102into an insertion geometry when the air chambers are under atmosphericair pressure, or in other words, when the air chambers are not inflated.Upon inflation, the air chambers can be configured to articulate thedevice array 102 into an installed geometry. In some embodiments, theinstalled geometry can be defined by the respective elasticities of theplurality of chambers and surrounding material. Using, for example,materials having a first elasticity for one wall of the plurality ofchambers and materials having a greater elasticity for another wall ofthe plurality of chambers results in material having the greaterelasticity distending to a greater extent than material having a lesserelasticity. This property can be configured to achieve a variety ofgeometries in any articulating array. In other embodiments, varioussections, portions, etc., of an articulating array can be constructed tohave a plurality of elasticities, permitting articulation into any oneor more of triangular, square, elliptical, ovular, and spherical shapes,among other examples.

In some embodiments, the articulating array is constructed and arrangedof a soft expandable material. For example, high expansion silicon canbe used to fabricate the articulating array using known approaches. Thearticulating array can be fabricated to include a plurality of chambers,and channels within the articulating array, where the channels are usedto control the expansion of the plurality of chambers (e.g., each arraycan include a plurality of chambers and a plurality of channels tointroduce air or fluid into one or more chambers thereby controlling theexpansion of the plurality of chambers). According to some embodiments,the articulating array can be constructed to have any of a variety ofinsertion geometries and articulate into any of a variety ofinstallation geometries. In some embodiments, the insertion geometryincludes a cylinder, so that the cross section of, for example, array102 is minimized.

In some further embodiments, the installed geometry of the articulatingarray includes a substantially triangular geometry to conform to patientphysiology during an intrauterine procedure. In one example, thetriangular geometry of the articulating array in its installed positionenables deployment of a conductive array within a patient. Theconductive array can be integrated on the outside of the articulatingarray (FIG. 3C, discussed in greater detail below). In some embodiments,the conductive array can be constructed and arranged on the surface ofthe articulating array, so that the conductive array is proximate to anablation surface when the articulating array is in an installedposition.

By releasing pressure on the plurality of chambers the articulatingarray can be configured to return to its insertion geometry,facilitating retraction of the articulating array from the patientand/or into the sheath.

Referring to FIG. 3A, the intrauterine therapy application device 100can be deployed from the sheath in its insertion geometry by driving thedevice array 102 forward relative to the sheath 104. Depending on theforces provided by the drive mechanism used to actuate the device array,the articulating array may or may not be driven forward to its maximumdepth. For example, a screw drive may be employed to drive forward thedevice array 102 into the insertion position shown in FIG. 3A. Thetravel of the device array 102 can be rigidly coupled to the travel ofthe screw drive. In some embodiments, the device array travels to afirst insertion position shown in FIG. 3A. The device array 102 can thenbe articulated into an installed geometry, which in some examplesresults in the articulating array moving forward relative to the deviceand/or sheath 104. In some implementations, the connection at the screwdrive can be configured to allow for forward travel by the articulatingarray 102 during subsequent articulation. In other embodiments, thescrew drive can also be configured to travel forward responsive to thearticulation of the articulating array 102 during transition from theinsertion geometry to the installed geometry.

In some examples, the connection between a screw drive can include acompliant element, such as a spring, between the screw drive and aninternal central support member. The spring transmits force from thescrew drive to the device array, so that if the deployment of the devicearray is unrestricted, the articulating array will deploy normally.Alternatively, in the event that the end of the articulating array isrestricted, the spring can absorb the screw's travel, allowing thearticulating array to rest at a sub-maximum deployment without heavystress. Further the compliant element can permit the articulating arrayto move forward further into, for example, the patient's uterusresponsive to articulation of the articulating array. In one example,the articulating array rolls into the installation geometry duringexpansion of the plurality of chambers.

The process of rolling the articulating array into the installationgeometry can cause the articulating array to be positioned more securelyinside the uterus by moving further into the uterine cavity. In someexamples, the compliant element can permit the additional movement ofthe articulating array. In other embodiments, the device can beconfigured to permit the articulating array to move freely duringarticulation of the articulating array. Thus, the forward pressureexerted by the articulating array causes the articulating array and, forexample, the screw drive to move forward.

In some aspects, the introduction of a compliant element to the screwdrive allows for a simple drive mechanism that controls the insertionforce that the articulating array is able to generate.

Functionally, a purpose of the articulating array of the intrauterinetherapy application device is to position a conductive array constructedon the surface of array 102 into a deployed state. An RF source (e.g.,RF generator 110) can be configured to deliver power to the conductivearray on the surface of the articulating array. Responsive to input ofpower from the RF generator, heat can be generated that ablates theuterine lining. In some embodiments, the conductive array can be knitfrom elastic yarn, so a certain level of force is needed simply tospread the conductive array to the desired shape. In some examples, theforce can be applied through expansion of the plurality of chambers. Inother embodiments, the conductive array can be printed and/orconstructed on the surface of the articulating array. The conductivearray can be printed and/or constructed on the surface of thearticulating array based on the installed geometry, thus when thearticulating array is transitioned into an installed geometry the meshon the surface of the articulating array can be positioned proximate to,for example, the patients uterine lining.

In addition to stretching and/or positioning the conductive array, thedevice 100 can be configured to overcome resistance encountered duringtransition from an insertion geometry to an installed geometry. Forexample, a pressure controller can be configured to increase pressuredelivered to the plurality of chambers until the articulating array isconfigured in its installed geometry. In some settings, the intrauterinedevice is configured to limit the pressure applied to the plurality ofchambers, and thereby prevent injury during a procedure, as described ingreater detail below.

According to one approach, improving the durability and flexibility ofthe articulating array includes constructing the articulating array of ahigh elongation material (e.g., silicone, rubber, etc.) to enable thearticulating array to be softer, more compliant/resilient, and/or betterform fitting so that the articulating array can endure significantstress and strain, and even displacement and/or deformation and stillreturn to an original configuration. This approach enables reduction inthe size of the articulating array and consequently the sheath andintrauterine device required. Further the strength of the highelongation materials can be configured to supply the desired pressurefor properly positioning of the conductive array. In some embodiments,an intrauterine device can include a vacuum and/or pump for supplyingincreasing pressures to the plurality of chambers. In other embodiments,pressured air or fluid can be driven into the plurality of chambers bymanual operation.

Referring again to the Figures, a detailed description of variousembodiments of such an intrauterine therapy application device and arraystructure will now be discussed. FIG. 1 is a side elevation view of anintrauterine therapy application device 100 with an articulating array102 in a retracted position inside a hollow sheath 104. The intrauterinetherapy application device 100 includes a handle 106, and is coupled viaa cable 120 to a radiofrequency signal generator 110 and via a tube 128to a vacuum/pump source 112. The radiofrequency generator 110 generatesan electrical signal, for example a radiofrequency signal, and transmitsit to the a conductive array disposed on the articulating array 102through the cable 120, which is ultimately coupled to the conductivearray through the handle 106. The vacuum/pump source 112 can beconnected to the handle 106 at the port 122. In some embodiments,vacuum/pump source 112 can create suction for removal of ablated tissue.In other embodiments, vacuum pump source can be connected to a pluralityof tubes (e.g., 128) connected to one or more ports (e.g., 122) tocontrol a pressure delivered to an articulating array 102 including aplurality of expansion chambers. According to one feature, the distalend 104 a of the sheath 104 of the intrauterine therapy applicationdevice 100 is configured to be inserted into a patient's cervix.

The handle 106 includes a distal grip 124 and a proximal grip 126.During use, the proximal grip 126 is squeezed toward the distal grip124, to cause the articulating array 102 to extend out from the sheath104, as shown in FIG. 2, for example, by operation of drive shaft 108.As shown in FIG. 2, the articulating array 102 is extended out from thesheath 104 in an insertion geometry or collapsed position as shaft 108is driven forward. As the articulating array 102 extends out from thesheath 104 in the insertion geometry or collapsed position, it may beconfigured to begin transitioning into the installed geometry, as shownin the perspective view of the deployed array illustrated in FIG. 3B. Insome embodiments, operation of proximal and distal grips can beconfigured to force air and/or liquid into the plurality of expansionschambers increasing the pressure in the plurality of expansion chamberscausing the chambers to expand into the installed geometry as thearticulating array 102 is fully extended from the sheath 104. In someembodiments, shaft 108 can be configured to operate on a fluid or airbladder and shaft 108 can be configured to apply pressure on the bladderwhen the proximal grip 126 is squeezed toward the distal grip 124. Theincrease in pressure can be communicated to the articulating array 102causing it to extend out from the sheath 104 and subsequently totransition into an installed geometry.

In other embodiments, the articulating array 102 may be configured toextend out from the sheath 104 until it reaches a preconfiguredposition. Once the articulating array 102 reaches the preconfiguredposition, a pressure controller can be operated to increase pressure inthe plurality of expansion chambers (e.g., 150, FIG. 3A) therebyarticulating the articulating array into an installed position.

In some embodiments, the preconfigured position can be set on theintrauterine device manually, for example via a dial 129, such as toaccommodate a specific patient's anatomy. In one embodiment, the dial129 can control a length of shaft 108. By manipulating the dial 129 anoperator can lengthen or shorten shaft 108. Lengthening and shorteningthe shaft 108 can be configured to alter the insertion distancetravelled by array 102. In other implementations, lengthening andshortening of the shaft 108 can be configured to alter a pressuredelivered to the plurality of chambers, which can be configured tocontrol insertion attributes (e.g., insertion depth, insertion geometry,etc.)

In other examples, a dial can also be configured to control a valve thatpermits a fluid (gas and/or liquid) to flow into the plurality ofexpansion chambers, so that in response to reaching the preconfiguredposition, the valve may open and pressurized fluid may be delivered tothe plurality of expansion chambers. In other embodiments, the dial cancontrol the activation of a switch or sensor that indicates thepreconfigured position has been reached. The switch or sensor cancontrol the opening of a valve that controls flow to the plurality ofexpansion chambers. In yet other embodiments, a pump or motor can beconfigured to deliver increased pressure to the plurality of expansionchambers once the preconfigured position has been reached. The switchand/or sensor can also be configured to deliver a control signal to thepump or motor that indicates that increased pressure can be delivered tothe plurality of expansion chambers.

In other embodiments, the articulating array 102 and the pressurecontroller can be configured to extend the articulating array from thesheath 104 with selective pressure applied to one or more of thechambers of the articulating array, while maintaining the plurality ofexpansion chambers in the insertion geometry. Rather than use a screwdrive, for example, the articulating array 102 can be configured toextend outward from the sheath 104 with increased pressure applied toone of more of the plurality of expansion chambers. In someimplementations, the plurality of expansion chambers can be arranged ina linear arrangement. In some embodiments, the pressure controller andthe plurality of expansion chambers can be configured to deliver anincreased pressure to one of more of the plurality of expansion chambersto extend the articulating array, and once the articulating array isextended from the sheath in the insertion geometry, the pressurecontroller can be configured to further selectively provide increasedpressure to the one or more of the plurality of expansion chambers toarticulate the articulating array into an installed position.

FIG. 3A is a perspective view of a portion of an intrauterine therapyapplication device array in a deployed position, according to anembodiment of the disclosure. The articulating array 102 includes aplurality of expansion chambers 150 and an external surface 151. Thearticulating array 102 can be constructed and arranged of a contiguousmaterial and configured to retain an insertion geometry when theplurality of expansion chambers 150 are not under pressure.

In some embodiments, the plurality of expansion chambers are constructedto include respective seals, and/or valves that enable selectiveinflation of the plurality of expansion chambers and/or facilitatetransition of the articulating array between the insertion and installedgeometries. The plurality of expansion chambers can be constructed andarranged to have a first geometry when not inflated or having a pressureless than a threshold and at least a second geometry when fully inflatedor having a pressure greater than a threshold. In some embodiments, thearticulating array can be configured to achieve various positions inbetween the insertion geometry and installed geometry by varying thepressure within select of the plurality of expansion chambers. In someimplementations, the plurality of expansion chambers are constructed andarranged of pneumatic networks (“pneunets”) of channels in elastomers.With such an arrangement, selective increases in pressure can besupplied to the plurality of expansion chambers, for example, throughthe pneumatic networks. With this arrangement, it is understood that thedelivery of selective increases in pressure to the plurality ofexpansion chambers can be used to provide rigidity to the articulatingarray, for example, to restore the articulating array to its insertiongeometry. For example, it is understood that the articulating array canbe deformed from an insertion geometry upon advancement from the sheathdue to, for example, gravity or the plurality of expansion chambersencountering some internal resistance to the advancement of thearticulating array. With such arrangement, a controller can beconfigured to selectively deliver increases in pressure to one or moreof the plurality of expansion chambers to overcome gravity or suchdeformation in the articulating array so as to restore the articulatingarray to its insertion geometry.

The articulating array can be connected to a drive shaft or an airbladder as discussed above, at 152. The spacing shown between 152 andthe end of the sheath 104 can be configured based on measurements takenof a patient's uterus. In some further embodiments, the spacing shownbetween 152 and the end of the sheath 104 can provide for some variationin a deployment distance. The connection at 152 is configured to providea telescoping arrangement whereby the articulating array 102 is extendedoutward from the sheath 104 when operated.

The articulating array 102 can include channels at 153, some can beconstructed and arranged to extend the length of the articulating array102. Channels 153 are configured to deliver fluid to the plurality ofexpansion chambers at 150. For example, vacuum/pump 112 can force fluidinto the plurality of expansion chambers 150, increasing fluid pressurewithin the expansion chambers. In another example, operation of thehandle (e.g., 124-126) can be configured to deliver increased pressureto the plurality of expansion chambers.

As shown in FIG. 3A, the articulating array 102 extends outward from thesheath 104 in an insertion geometry defined by the outer surface 151 andshape of the plurality of expansion chambers 150. In other embodiments,additional expansion chambers can be constructed and arranged withinarticulating array 102, and in some further embodiments, fewer expansionchambers can be constructed and arranged within articulating array 102.

Referring back to FIG. 3A, according to one embodiment, the articulatingarray can include one or more hollow elongate tubes (not shown). Whensuction is applied to the uterine cavity, for example from the suctionsource (e.g., 112 shown in FIG. 1), fluid, vapor, liquid, and/or tissuemay be suctioned through the one or more hollow elongate tubes, awayfrom the patient.

FIG. 3B is a perspective view of the portion of an intrauterine therapyapplication device in a installed position. As shown, the articulatingarray 102 and a plurality of expansion chambers at 160 have beenexpanded to cause the articulating array to transition from an insertiongeometry (FIG. 3A) to an installed geometry (FIG. 3B). According to someembodiments, the articulating array can also include a conductive array(e.g. FIG. 3C, 170) on an outer surface 161 of the articulating array102. The conductive array can be, for example, printed on the outersurface 161 of the articulating array 102 so that the conductive arrayis proximate to a patient's uterine lining when the articulating array102 is in an installed geometry (FIG. 3B). The conductive array may beknitted from a nylon and spandex knit and plated with gold, silver, oranother conductive material. The conductive array can be configured tobe conformable, permeable, and to carry current. In some embodiments,the conductive array can be attached to the articulating array at itsouter surface 161. For example, strands of thread may be connected tothe outer surface 161 of the articulating array 102. The strands ofthread can be constructed of nylon. In some examples, the strands ofthread forming the conductive array can be sewn into the articulatingarray 102 at the outer surface 161.

In other embodiments, conformable metal filaments can be printeddirectly on the outer surface of the articulating array 102. In someother embodiments, metal filaments (e.g., gold, silver, or anotherconductive material) can be attached to the outer surface of thearticulating array 102. In further embodiments, other filaments (e.g.,non-metal) to carry current can be printed and/or attached to the outersurface of the articulating array 102. The articulating array may beconnected to a drive or a first expansion chamber at 162. The connectionat 162 can be configured to allow some variability in an insertiondistance traveled by the articulating array 102. In other embodiments,the connection 162 can travel further out from sheath 104 as thearticulating array 102 transitions from an insertion geometry into aninstalled geometry.

The conductive array can be configured to carry current. Shown in FIG.3C is an example conductive array disposed on the surface of anarticulating array 102. Internal wires 172A and 172B can be configuredto deliver current to the conductive array from, for example and RFsource (e.g., RF 110, FIG. 1). The amount of current delivered to theconductive array can be configurable according to a geometry of theinstalled articulating array 102 and/or the conductive array disposed onits surface. In one example, the installed geometry of the articulatingarray 102 is approximately triangular. For the triangular geometry thepower delivered can be calculated based on a desired power density,which can be determined from power divided by the surface area to whichpower is being delivered. Other geometries can require differing amountsof current to be delivered to the conductive array, for example, basedon the surface area of the other geometry. As discussed, the differingamount of current can be controlled by an RF source 110 connected to aconductive array.

Conductive arrays can be constructed and arranged on an outer surface ofan articulating array 102 in a variety of structures. FIG. 3Dillustrates an example conductive array constructed and arranged of aplurality of mesh portions shown at 180. Each mesh portion can beprinted on a portion of an outer surface of the articulating array 102.Each mesh portion can be connected to wires 182A-B which can beconnected to an RF source to supply current to each mesh portion. Asdiscussed, the conductive array may be knitted from a nylon and spandexknit and plated with gold, silver, or another conductive material. Eachmesh portion may also be knitted from a nylon and spandex knit andplated with gold, silver, or another conductive material. In otherembodiments, filaments (e.g., metal, gold, silver, or another conductivematerial) can be printed on the outer surface of an articulating array102 to form each mesh portion at 180. Once positioned, current can besupplied to each mesh portion to perform an ablation procedure on apatient's uterine lining.

In some embodiments, the articulating array can be fabricated without aconductive array. For example, in embodiments without a conductivearray, the uterine lining could be ablated using hot or cold fluidintroduced into the plurality of expansion chambers. In oneimplementation, refrigerants can be introduced into the articulatingarray to ablate the uterine lining. The refrigerants can include, forexample, liquid nitrogen and nitrous oxide, among other options. In someembodiments, the articulating array can be fabricated with the pluralityof expansion chambers constructed to position the articulating array inoptimal communication with the uterine lining of a patient. According tosome embodiments, the articulating array can include additional channelsfor delivering hot or cold fluid proximate to the surface of thearticulating array in contact with the uterine lining. In otherembodiments, the hot or cold fluid can be introduced into the pluralityof expansion chambers to ablate the uterine lining.

It is appreciated that several properties of construction of thearticulating array (e.g., 102) can be controlled to adjust stiffness andcreate a flexure with a plurality of expansion chambers, each having avariety of stiffnesses and expansion geometries. Once the plurality ofexpansion chambers are expanded the articulating array can take on avariety of installation geometries. Shown in FIGS. 4A-C are exampleinstallation geometries that can be obtained by expanding a plurality ofexpansion chambers within an articulating array (e.g., triangular FIG.4A, circular FIG. 4B, and diamond FIG. 4C). For example, selectedmanufacturing processes can be used to alter the elasticity provided bydifferent portions of the articulating array (e.g., combining differentmaterials, using different thicknesses for dimensions of respectiveexpansion chambers, etc.). The manufacturing processes can be usedselectively on different areas of an articulating array to create anarticulating array of a plurality of expansion chambers having differentelasticities in different areas of the articulating array. In somefurther examples, the articulating array may be constructed of multiplematerials, each material having a different modulus of elasticity. In afurther example, the cross-sectional profile of each expansion chamber,such as the thickness and/or width of the chamber, may be adjusted tocreate an expansion chamber having an expanded geometry that forces thearticulating array to take on an installation geometry when theindividual chambers comprising the articulating array are expanded.

It is appreciated that adjusting the cross-sectional profile of one ormore of the expansion chambers can alter the geometry obtained by agiven embodiment of the articulating array, when the plurality ofexpansion chambers are being expanded. In further embodiments, othermethods and characteristics may be used to control the stiffness ofcertain portions of an articulating array so as to alter the geometryand/or overall volume obtained by the articulating array. Additionally,varying pressure can be selectively applied to one or more of theplurality of expansion chambers to trigger articulation of thearticulating array in a desired manner during transition from theinsertion geometry to the installed geometry. In one embodiment, thepressure controller and the articulating array can be selectivelycontrolled to transition to one or more intermediate positions of thearticulating array from an insertion geometry (e.g., FIG. 3A) to theinstalled geometry (e.g., shown in FIGS. 4A-4C) much like a frondunfolds, except in reverse. With such an arrangement, the shape and/oroverall volume that the articulating array takes in the one or moreintermediate positions during the transition from the insertion geometryto the installed geometry can be controlled through the selectiveinflation of the plurality of expansion chambers. It is appreciated thatwith such an arrangement, the the shape and/or the overall volume of thearticulating array in the intermediate positions between the insertiongeometry and the installed geometry can be controlled to minimize theoverall volume occupied by the articulating array during the transition,such as to yield to neighboring tissue. This may be desirable, forexample, so as to increase patient comfort during the transition fromthe insertion geometry of the articulating array to the installedgeometry of the articulating array.

In FIG. 6 illustrated is an example process for ablating the uterinelining of a patient using a therapy device having an articulating array.Process 600 begins at 602 with an operator inserting a sheath of thetherapy device into the cervix of the patient. Once the sheath has beenpositioned, the articulating array of the device is extended outwardfrom the sheath at 604. Pressured can be delivered to the articulatingarray, for example, by increasing fluid pressure delivered to thearticulating array through the therapy device. The increased pressureresults in actuation of the articulating array. At 606 the articulatingarray transitions from an insertion geometry to an installed geometrywithin the uterus of the patient. Once the articulating array has beenpositioned within the patient's uterus, a conductive array on thearticulating array is also position proximate to the patient's uterinelining. At 608, power can be supplied to the conductive array ablatingthe uterine lining of the patient. In some examples, power can bedelivered by an RF source connected to the therapy device. In somefurther examples, the RF source can be managed by a controller. Thecontroller can also be configured to mange and/or monitor pressure andtemperature during the procedure. The controller can be configured toalter pressure or power delivered in order to insure patient health andsafety.

Shown in FIG. 5 is a portion of an articulating array 500 includingexpansion chambers 510, 512, and 514. Increased pressure delivered tochambers 510-514 can result in the portion of the articulating arraytaking on an installed geometry defined by the elasticity of thechambers. In some embodiments, the articulating array can be fabricatedto include a plurality of sensors 502, 504, and 506. The plurality ofsensors can be disposed on an exterior surface of the articulating arrayor can be embedded within the articulating array structure. In someexamples, pressure sensors can be configured to detect pressure with theplurality of chambers. In other examples, sensors (e.g., 502-506) can beconfigured to determine a change in dimension of the plurality ofchambers. The change in dimensions can be communicated to a pressurecontroller. The pressure controller can be configured to determine that,for example, the pressure supplied has resulted in a smaller change inconfiguration than expected. Smaller changes in configuration can beassociated with resistance, prompting an increase in pressure deliveredto the plurality of chambers and/or an articulating array. Proximitysensors can also be employed to assist in deployment and positioning ofan articulating array. In one example, strain gauges can be included inthe plurality of sensors. The strain gauges can provide information to acontroller to establish that the articulating array has or has notreached an installed position. Further, temperature sensors can beconstructed within and/or on the surface of the articulating array andtemperatures applied to the patient, for example, by current through aconductive array can be monitored to insure the temperature remain belowa safe operating temperature. Other sensors can also be fabricated on orin the articulating array. According to some embodiments, sensorinformation can be communicated to a controller. The controller can beconfigured in some embodiments to respond to the sensor informationautomatically, or in other embodiments to provide indications to anoperator regarding the sensor information. In further embodiments, thecontroller can be configured to respond automatically and report tovarious operators. For example, sensors can signal the controller toturn off portions of a conductive array on non-expanded portions of thearticulating array to prevent electrical shorts, among other options.

Shown in FIG. 7 is an example controller which can be configured to, forexample, regulate pressure delivered to an articulating array. In otherembodiments, the controller can receive sensor information from anintrauterine therapy application device. The controller can beconfigured to process the information and act on the intrauterinetherapy application device according to the received information. Forexample, if the sensor information indicates that the articulating arrayhas not reached an installed geometry, increased pressure can bedelivered to the device to achieve the installed geometry. In oneembodiment, the controller can be connected to a vacuum/pump and controlthe pressure supplied to the device.

In another example, the controller 700 can be configured to manage powerdelivered to an intrauterine therapy application device. In someexamples, the controller can be configured to receive sensor informationon position and/or temperature. The controller can be configured tolimit power delivered from, for example, an RF source to the conductivearray until the articulating array is in an installed position. Further,the controller can also be configured to maintain procedure appropriatetemperature being applied to the patient. If a threshold temperature isexceeded, the controller can be configured to reduce or cease powersupplied from the RF source to the conductive array.

As discussed, FIG. 7 shows an example block diagram of the controller700, which can be implemented as a computer system, in which variousaspects and functions in accordance with the present disclosure may bepracticed. The controller 700 may include one or more computer systemsconnected via a network. The computer systems may include mobilecomputing systems displaying user interfaces for interacting with thefunctions and/or sensor information provided by the controller (e.g.,laptops, tablets, and other mobile devices). The user interfaces can beconfigured to allow an operator to make adjustments to the operation ofthe flexible array during a procedure.

Various aspects and functions in accord with the present disclosure maybe implemented as specialized hardware or software executing in one ormore computer systems including the controller 700 shown in FIG. 7. Asdepicted, the controller 700 includes a processor 710, a memory 712, abus 714, an interface 716 and a storage system 718. The processor 710,which may include one or more microprocessors or other types ofcontrollers, can perform a series of instructions that manipulate data.The processor 710 may be a well-known, commercially available processorsuch as an Intel Pentium, Intel Atom, ARM Processor, Motorola PowerPC,SGI MIPS, Sun UltraSPARC, or Hewlett-Packard PA-RISC processor, or maybe any other type of processor or controller as many other processorsand controllers are available. As shown, the processor 710 is connectedto other system placements, including a memory 712, by the bus 714.

The memory 712 may be used for storing programs and data duringoperation of the controller 700. Thus, the memory 712 may be arelatively high performance, volatile, random access memory such as adynamic random access memory (DRAM) or static memory (SRAM). However,the memory 712 may include any device for storing data, such as a diskdrive or other non-volatile storage device, such as flash memory orphase-change memory (PCM). Various embodiments in accord with thepresent disclosure can organize the memory 712 into particularized and,in some cases, unique structures to perform the aspects and functionsdisclosed herein.

Components of the controller 700 may be coupled by an interconnectionelement such as the bus 714. The bus 714 may include one or morephysical busses (for example, busses between components that areintegrated within a same machine), and may include any communicationcoupling between system placements including specialized or standardcomputing bus technologies such as IDE, SCSI, PCI and InfiniBand. Thus,the bus 714 enables communications (for example, data and instructions)to be exchanged between system components of the controller 700.

Controller 700 can also include one or more interfaces 716 such as inputdevices, output devices and combination input/output devices. Theinterface devices 716 may receive input, provide output, or both. Forexample, output devices may render information for externalpresentation. Input devices may accept information from externalsources. Examples of interface devices include, among others, keyboards,mouse devices, trackballs, microphones, touch screens, printing devices,display screens, speakers, network interface cards, etc. The interfacedevices 716 allow the controller 700 to exchange information andcommunicate with external entities, such as users and other systems.

Storage system 718 may include a computer-readable andcomputer-writeable nonvolatile storage medium in which instructions arestored that define a program to be executed by the processor. Thestorage system 718 also may include information that is recorded, on orin, the medium, and this information may be processed by the program.More specifically, the information may be stored in one or more datastructures specifically configured to conserve storage space or increasedata exchange performance. The instructions may be persistently storedas encoded signals, and the instructions may cause a processor toperform any of the functions described herein. A medium that can be usedwith various embodiments may include, for example, optical disk,magnetic disk or flash memory, among others. In operation, the processor710 or some other controller may cause data to be read from thenonvolatile recording medium into another memory, such as the memory712, that allows for faster access to the information by the processor710 than does the storage medium included in the storage system 718. Thememory may be located in the storage system 718 or in the memory 712.The processor 710 may manipulate the data within the memory 712, andthen copy the data to the medium associated with the storage system 718after processing is completed. A variety of components may manage datamovement between the medium and the memory 712, and the invention is notlimited thereto.

Further, the invention is not limited to a particular memory system orstorage system. Although the controller 700 is shown by way of exampleas one type of computer system upon which various aspects and functionsin accord with the present invention may be practiced, aspects of theinvention are not limited to being implemented on the computer system,shown in FIG. 7. Various aspects and functions in accord with thepresent invention may be practiced on one or more computers havingdifferent architectures or components than that shown in FIG. 7.

Having described above several aspects of at least one embodiment, it isto be appreciated various alterations, modifications, and improvementswill readily occur to those skilled in the art. Such alterations,modifications, and improvements are intended to be part of thisdisclosure and are intended to be within the scope of the invention.Accordingly, the foregoing description and drawings are by way ofexample only.

What is claimed is:
 1. An intrauterine ablation device, comprising: asheath configured for transcervical introduction; an articulating arrayslidably disposed within the sheath and comprising at least threeserially disposed expansion chambers, the articulating array having aninsertion geometry in which the expansion chambers are linearly alignedin a deflated configuration that may be inserted into a uterus throughthe sheath, and an installed geometry, in which the expansion chambersare inflated and are rolled into a non-linear configuration; aconductive array disposed on a surface of the articulating array,wherein the conductive array is configured to contact uterine walltissue when the conductive array is inserted into the uterus andtransitioned to the installed geometry; and a port configured to receivean inflation media, wherein delivery of the inflation media to theexpansion chambers causes the articulating array to transition from theinsertion geometry to the installed geometry.
 2. The intrauterineablation device of claim 1, the at least three serially disposedexpansion chambers of the articulating array including at least first,second and third expansion chambers, wherein the second expansionchamber is disposed between the first and third expansion chambers, sothat a proximal portion of the second expansion chamber is disposedadjacent to a distal portion of the first expansion chamber, and adistal portion of the second expansion chamber is disposed adjacent to aproximal portion of the third expansion chamber, wherein when thearticulating array is positioned within a uterus via the sheath, andtransitioned from the insertion geometry to the installed geometry, therespective first, second and third expansion chambers place theconductive array into contact with uterine wall tissue.
 3. Theintrauterine device of claim 1, wherein the conductive array comprises amesh structure.
 4. The intrauterine device of claim 1, wherein thearticulating array further comprises a plurality of channels fluidlycoupled to the expansion chambers for delivering and/or withdrawing theinflation media to the expansion chambers through the channels.
 5. Theintrauterine device of claim 1, wherein inflation of the expansionchambers causes the articulating array to transition from the insertiongeometry into the installed geometry.
 6. The intrauterine device ofclaim 1, wherein the installed geometry comprises a furled frond-likeconfiguration.
 7. The intrauterine device of claim 1, further comprisinga contact sensor disposed on an outer surface of the articulating array.8. The intrauterine device of claim 1, further comprising a strain gaugecoupled to the articulating array.
 9. The intrauterine device of claim1, further comprising at least one sensor configured to sense theinstalled geometry of the articulating array.
 10. The intrauterinedevice of claim 1, further comprising at least one inflation memberhaving an inflation lumen fluidly coupled to the expansion chambers,with a proximal end of the inflation member configured for fluidlycoupling the inflation lumen with a source of inflation media.
 11. Theintrauterine device of claim 1, further comprising a controllerconfigured to control pressure within the expansion chambers so as totransition the articulating array between the insertion geometry and theinstalled geometry.
 12. The intrauterine device of claim 1, wherein theinstalled geometry is defined by an elasticity of the expansionchambers.
 13. The intrauterine device of claim 1, wherein the installedgeometry is triangular, circular, or diamond-shaped.